Director, Epidemiology Registries

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Introduction to role

In this senior strategic and scientific role, the Director, Epidemiology provides global direction and leadership to the Alexion-sponsored global Registry programs requiring minimal supervision. The Director, Epidemiology is the primary point of contact within the Epidemiology department for the Alexion-sponsored Registries, supporting rare disease real-world evidence generation. The Director, Epidemiology will have direct oversight of contract personnel and vendors associated with the planning, implementation, and execution of Epidemiology evidence generation activities within the Registries, with deliverables aimed at publications and regulatory agency submissions. The Director, Epidemiology also ensures all Registry analytical deliverables are performed in the most efficient manner possible, commensurate with budget, quality, accuracy, and timeliness, and in accordance with current advancements in pharmacoepidemiology methodology. The Director, Epidemiology will build a strategic plan for Registries that meets corporate needs and follows policies. The Director, Epidemiology will collaborate with other therapeutic area lead Epidemiologists to ensure the appropriate epidemiological perspectives are provided in support of strategic needs and are incorporated into the plan.

The Director, Epidemiology involves collaborating with various teams, regularly working with Registry leadership within Clinical Operations, Statistical Programming, Data Management, Patient Safety, Regulatory Affairs, Medical Writing, Scientific Communications, and Global Medical Affairs. Experience in collaborating across functions for project goals is essential. Understanding and meeting customer needs with skills like persuasion and negotiation are key. Additionally, the Director, Epidemiology may be tasked with representing the Epidemiology department in interactions with external partners, such as Scientific Advisory Boards or regulatory authorities.

The Director, Epidemiology may participate in cross-functional initiatives in support of Alexion business or process improvement initiatives. The Director, Epidemiology may also represent the Epidemiology department in other cross-functional teams throughout the development lifecycle and provide guidance to other Epidemiologists who participate on such teams. Within the Epidemiology department, the Director, Epidemiology provides expert technical guidance to the Registries and mentoring to other Epidemiologists. The Director, Epidemiology may support the Global Head in developing writing and maintenance of department Standard Operating Procedures and Process Guides, as well as annual Epidemiology department objectives, which encompass project planning and resource forecasting.

Ability to think strategically and leverage epidemiologic expertise and experience across a wide variety of diseases is essential. Strong planning and execution ability, along with excellent communication skills, both written and oral are essential. Additionally, the Director, Epidemiology is well-versed in and experienced with epidemiologic methods, including observational study design, analysis, and interpretation, methods used in quantifying potential safety signals, disease epidemiology, and determining cause-and-effect relationships.

This position will oversee the conduct of work performed by contractors in the Epidemiology department. Taking responsibility for professional development of self and other colleagues are crucial skills for this position. Teaching and mentoring within the department are expected. It is also expected that the Director, Epidemiology will routinely publish and present epidemiology projects at external industry conferences/workshops and maintain excellent relationships with external clinical advisors and epidemiological experts in the professional community.

Accountabilities

• Accountable for developing a strategic plan for Epidemiology evidence generation activities within the Alexion-sponsored Registries to support company objectives.
• Responsible for leading all aspects of contract personnel and vendors to ensure Epidemiology evidence generation deliverables are completed in accordance with the plan.
• Accountable for serving as the primary point of contact within the Epidemiology department for the Alexion-sponsored Registries, providing Epidemiology leadership to Clinical Operations, Statistical Programming, Data Management, Patient Safety, Regulatory Affairs, Medical Writing, Scientific Communications, and Global Medical Affairs.
• Accountable for ensuring epidemiology perspective into company materials e.g., study protocols, case report forms (CRFs), and regulatory documents associated with the Alexion-sponsored Registries.
• Interact with authors, referees, and in-house reviewers on scientific manuscripts, clinical conference abstracts, presentations, and posters.
• Represent the Epidemiology department during interactions with key external collaborators like Scientific Advisory Boards and regulatory authorities.
• Critical appraisal and synthesis of relevant epidemiological literature.
• Maintain awareness of epidemiology with respect to regulatory requirements, payer trends, and advancement of pharmacoepidemiology methods.
• Represent the Epidemiology Department and participate in corporate cross-functional business/process improvement initiatives.
• Actively participate in developing and maintaining Epidemiology department Standard Operating Procedures/Process Guides.
• Travel may be required (up to 10%).

Essential Skills/Experience

• PhD / DSc / DrPH in Epidemiology with at least 6 years industry experience in the pharmaceutical industry, biotechnology, or consulting environment, or MPH/MSc in Epidemiology with at least 10 years industry experience in the pharmaceutical industry, biotechnology, or consulting environment.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience

• Excellent oral and written communication skills
• Knowledge of drug and clinical development process
• Excellent attention to detail and quality, and scientific rigor
• Ability to work effectively in multidisciplinary teams
• High degrees of self-motivation and organization
• Comfort in a fast-moving environment with frequent changes in scope or direction of projects
• Thorough and up-to-date technical knowledge of epidemiology and relevant biostatistics methods
• Experience and familiarity using SAS or other statistical software packages
• Evidence of productivity in epidemiological research as demonstrated by successful design, execution, and publication of epidemiological research
• 2 years of line management or supervisory experience or equivalent
• Record of high-quality publications in peer-reviewed journals

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.